We inspected your seafood processing facility, located at 3300 NW 123rd Street, Miami, FL on January 18-20 and January 25-26, 2012. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act),[21 U.S.C. § 342(a)(4)]. Accordingly, your Smilin’ Bob’s Smoked Fish Dip, Beck’s Smoked Tuna Spread, and pasteurized crab meat products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

You must have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for “Ready-to-Eat Seafood” does not list the food safety hazard of histamine formation associated with your Smilin’ Bob’s Smoked Fish Dip (contains amberjack) and Beck’s Smoked Tuna Spread (contains tuna).

You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for “Ready-To-Eat-Seafood” lists a critical limit of “Product properly iced and in cooler” at your Storage CCP, that is not adequate to control pathogenic bacteria growth as a result of temperature abuse. Furthermore, you do not specify a refrigeration temperature in your critical limit.

You must implement the monitoring and verification procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). Your firm did not follow the monitoring procedures at your receiving Critical Control Point (CCP) to control histamine formation listed in your HACCP plan for “Histamine Fish Group”, nor at your receiving CCP to control pathogen growth and toxin formation in your HACCP plan for “Ready-to-Eat Seafood.” Furthermore, you did not follow the verification procedures listed in your HACCP plans for Groups 2, 3, 4, and 5. For example:

You did not implement your monitoring procedure at the receiving CCP in your HACCP plan for “Histamine Fish Group” which lists “Presence of ice/coolant or temperature during transport.” You told our investigators that your procedure is to measure the internal temperature of the truck and one fish product upon receipt. This practice is inadequate to ensure that product was transported under appropriate temperature controls.

You did not implement your monitoring procedures at the receiving CCP in your HACCP plan for “Ready-to-Eat Seafood”. Your HACCP plan states that you will monitor the “presence of ice or product temperature at or below 40º F.” During the inspection, you received pasteurized crab meat that was not received on ice. You were unable to provide our investigators documentation to show that this product was maintained at or below 40º F during transit. Furthermore, you told our investigators that pasteurized crab meat is not received on ice nor do you require transit temperature documentation from your suppliers. You stated that your procedure is to measure the internal temperature of the truck and check the temperature of one fish product upon receipt, which is inadequate to ensure compliance with your critical limit.

You failed to implement your verification procedure at the receiving CCP in your HACCP plans for Groups 2 (“Histamine Fish Group”), 3 (“Clams, Mussels, Oysters”), 4 (“Ready-to-Eat Seafood”), and 5 (“Non-Scombroid Species – Reduced Oxygen Pack”), which list a verification procedure of “weekly record reviews.” You did not implement this procedure for at least the month of December 2011, as no weekly record reviews were conducted.

You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for “Histamine Fish Group” lists a monitoring procedure/frequency at the storage CCP that is not adequate to control histamine formation. Your monitoring procedure of “Temperature reading” is inadequate. Furthermore, you told our investigators that temperatures taken from your continuous temperature monitoring system are not reviewed and a temperature check is conducted twice daily. This frequency is inadequate to control the hazard of histamine formation.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.